OCREVUS (Ocrelizumab) Data Show Early Initiation of Treatment Reduces Disability Progression Over Five Years in Relapsing and Primary Progressive Multiple Sclerosis

Wed October 10, 2018 1:00 AM|Business Wire|About: RHHBY 

 EAST HANOVER, N.J., Oct. 9, 2018 /PRNewswire/  

Novartis analysis shows crizanlizumab (SEG101) increased the number of patients free of sickle cell pain crises vs placebo during SUSTAIN study

 NVS 

 New Analyses from Pivotal Phase 3 Trials of Oral Ozanimod to Be Presented at ECTRIMS 2018

Wed October 10, 2018 7:30 AM|Business Wire|About: CELG 

 Incyte Announces Data for Pemigatinib, its Selective FGFR Inhibitor, to be Featured at the ESMO 2018 Congress

Tue October 9, 2018 7:30 AM|Business Wire|About: INCY 

 BeiGene Announces National Reimbursement Inclusion of VIDAZA® (Azacitidine for Injection) by the State Medical Insurance Administration in China

Wed October 10, 2018 6:00 AM|GlobeNewswire|About: BGNE 

 New analysis estimates the positive impact of Jardiance® on life expectancy in adults with type 2 diabetes and established cardiovascular disease

Wed October 10, 2018 6:30 AM|PR Newswire|About: LLY 

  Novartis to Launch Innovation Labs Across the Globe, Including Silicon Valley

Published: Oct 09, 2018 By Alex Keown

  2018 BioSpace.com.  

 Janssen Reports Switching to SYMTUZA™ Results in Maintained High Virologic Suppression and No Resistance Development up to 96-Weeks in Virologically Suppressed 

 SAN FRANCISCO, OCTOBER 3, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson unveils new 96-week data for SYMTUZA™ (darunavir 200 mg, cobicistat 150 mg, emtricitabine 200mg, and tenofovir alafenamide 10 mg; D/C/F/TAF),  Adults with HIV-1 

 Merck snags national VA contract for its Remicade biosimilar thanks to discount pricing offer

by Eric Sagonowsky | Oct 8, 2018 11:12am  

Merck has a biosimilars partnership with South Korea's Samsung Bioepis. (Merck)

Merck’s Renflexis hasn’t made much of a splash on the market since its FDA approval last April, but the company has now won business with the Department of Veterans Affairs thanks to a pricing offer that beat out its rivals.

 Novartis Looks To Maintain Market Strength In Multiple Sclerosis Space

 Terry Chrisomalis
Oct. 9, 2018 11:22 AM ET  | About: Novartis AG (NVS), Includes: BIIB, CELG 

 Single dose of J&J's Stelara shows treatment effect in late-stage UC study

Oct. 9, 2018 8:59 AM ET|By: Douglas W. House, SA News Editor  

 Janssen Announces Exclusive, Worldwide License Agreement with Arrowhead Pharmaceuticals to Develop and Commercialize a New Treatment for Chronic Hepatitis B Viral Infection 

 TITUSVILLE, N.J., October 4, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Janssen Pharmaceuticals, Inc., (Janssen) has entered into an agreement with Arrowhead Pharmaceuticals, Inc., (Arrowhead) for an exclusive, worldwide license to develop and commercialize ARO-HBV, a Phase 1/2 subcutaneous, ribonucleic acid interference (RNAi) therapy candidate being investigated for the treatment of chronic hepatitis B viral infection. 

 Celgene Announces Phase 3 STYLE Study of OTEZLA® (apremilast) in Moderate to Severe Scalp Psoriasis Met Primary Endpoint

Mon October 8, 2018 4:37 PM|Business Wire|About: CELG 

 Lilly to Present New Data From Oncology Portfolio at ESMO 2018 Congress, Showcasing Patient-Centric Advances in Cancer Care

Mon October 8, 2018 6:05 PM|PR Newswire|About: LLY 

 Merck’s Broad Oncology Pipeline to Be Highlighted at ESMO 2018 Congress

Tue October 9, 2018 6:30 AM|Business Wire|About: MRK 

 Libtayo® (cemiplimab-rwlc) Data at ESMO 2018 Congress Provide New Insights in Six Tumor Types Under Investigation

Mon October 8, 2018 6:05 PM|PR Newswire|About: REGN 

 Genentech to Present New Positive Data from Its Broad Cancer Immunotherapy Program and across a Wide Range of Cancers at the European Society for Medical Oncology (ESMO) 2018 Congress

Tue October 9, 2018 1:00 AM|Business Wire|About: RHHBY 

 BeiGene to Present Clinical Data on Zanubrutinib and Pamiparib at Upcoming Medical Meetings

Mon October 8, 2018 6:05 PM|GlobeNewswire|About: BGNE 

 Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients

Oct 08, 2018

 NEW SPINRAZA® (NUSINERSEN) DATA PRESENTED AT ANNUAL CONGRESS OF THE WORLD MUSCLE SOCIETY DEMONSTRATE BENEFITS IN TREATING PRESYMPTOMATIC INFANTS WITH SPINAL MUSCULAR ATROPHY

October 6, 2018 at 7:30 AM EDT 

 IMRALDI™, Biogen’s Adalimumab Biosimilar Referencing Humira®, Is Launched in the European Union

Wed October 17, 2018 2:00 AM|GlobeNewswire|About: BIIB 

 Loxo Oncology Announces LOXO-292 Durability Update in Patients with RET-Mutant Medullary Thyroid Cancer and RET Fusion-Positive Thyroid Cancer from LIBRETTO-001 at the 88th Annual Meeting of the American Thyroid Association

Released on Oct 06, 2018

 New Real-World Data Analyses Support the Long-Term Use of Entyvio® (vedolizumab) in Bio-Naïve Patients for the Treatment of Moderate to Severe Ulcerative Colitis or Crohn's Disease

Mon October 8, 2018 8:00 AM|PR Newswire|About: TKPYY 

 Exelixis Initiates Phase 3 Pivotal Trial (COSMIC-311) of Cabozantinib in Patients with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

Mon October 8, 2018 8:00 AM|Business Wire|About: EXEL 

 INDIANAPOLIS, Oct. 4, 2018 /PRNewswire/   

Lilly's Investigational Dual GIP and GLP-1 Receptor Agonist Shows Significant Reduction in HbA1c and Body Weight in People With Type 2 Diabetes

Thu October 4, 2018 6:45 AM|Business Wire|About: MRK

 Merck’s HIV Therapy DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) Meets Primary Efficacy Endpoint in Phase 3 DRIVE-SHIFT Study Evaluating Switch to DELSTRIGO from Other Antiretroviral Treatment Regimens

 Health Canada OKs AbbVie's elagolix for endometriosis-related pain

Oct. 6, 2018 2:20 PM ET|About: AbbVie Inc. (ABBV)|By: Douglas W. House, SA News Editor  

 Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy

Wed October 3, 2018 8:30 AM|Business Wire|About: GILD

– Biktarvy Showed High Efficacy and a Demonstrated Tolerability Profile Through 96 Weeks –

 New SPINRAZA® (nusinersen) Data Presented at Annual Congress of the World Muscle Society Demonstrate Benefits in Treating Presymptomatic Infants with Spinal Muscular Atrophy

Sat October 6, 2018 7:30 AM|GlobeNewswire|About: BIIB 

 FDA OKs expanded use for Merck's Gardasil 9 HPV vaccine

Oct. 5, 2018 4:58 PM ET|About: Merck & Co Inc. (MRK)|By: Douglas W. House, SA News Editor 

 Thu September 27, 2018 7:52 PM|PR Newswire|About: LLY

INDIANAPOLIS, Sept. 27, 2018 /PRNewswire/ -- Eli Lilly and Company (LLY) 

Lilly's Emgality™ (galcanezumab-gnlm) Receives U.S. FDA Approval for the Preventive Treatment of Migraine in Adults

  Thu September 27, 2018 5:41 PM|Business Wire|About: PFE 

 NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) 

U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer

 by Nick Paul Taylor | 

Sep 28, 2018 7:33am

 Roche has paid €70 million ($81 million) upfront to buy Tusk Therapeutics. The takeover gives Roche control of an anti-CD25 antibody that depleted levels of regulatory T cells (Tregs) in preclinical tests 

  Sep. 28, 2018 7:07 AM ET|About: Novo Nordisk A/S (NVO)|By: Douglas W. House, SA News Editor 

Novo's once-weekly somapacitan on par with daily Norditropin in mid-stage study

 Thursday, September 20, 2018 - 8:00amEDT

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE)

 PFIZER GRANTED FDA BREAKTHROUGH THERAPY DESIGNATION FOR 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE FOR THE PREVENTION OF INVASIVE DISEASE AND PNEUMONIA IN ADULTS AGED 18 YEARS AND OLDER

 SAN DIEGO, Sept. 27, 2018 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP)  

Adamis Pharmaceuticals Receives FDA Approval for Its Lower Dose Symjepi Product 

 Novartis (NYSE:NVS) unit Sandoz will commercialize. 

 September 26, 2018 07:00 PM EDT  

TOKYO & INDIANAPOLIS--(BUSINESS WIRE)--

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519, Chugai) and Eli Lilly and Company(NYSE: LLY, Lilly) today announced they have entered into a license agreement for OWL833, Chugai’s oral non-peptidic GLP-1 receptor agonist. OWL833 is a Phase 1-ready asset that is being studied for the treatment of type 2 diabetes. 

 Wed September 26, 2018 7:30 AM|PR Newswire|About: AGN 

DUBLIN, Sept. 26, 2018 /PRNewswire/ -

- Allergan plc  (AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine), seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults in the current product lab

Sep. 26, 2018 9:13 PM ET|About: Abbott Laboratories (ABT)|By: Douglas W. House, SA News Editor 

Abbott (NYSE:ABT) announces that its High Sensitive Troponin-I blood test, used to predict the risk of a heart attack months or years in advance in otherwise healthy people, is now CE Mark certified.

 Tue September 25, 2018 9:00 AM|Business Wire|About: RHHBY 

 Genentech’s TECENTRIQ in Combination with Chemotherapy Helped People Live Significantly Longer as an Initial Treatment for People with Extensive-Stage Small Cell Lung Cancer

 Tue September 25, 2018 9:00 PM|Business Wire|About: A 

 Agilent to Expand Portfolio and Capabilities in Cell Analysis with Acquisition of ACEA Biosciences

 PR Newswire

SAN DIEGO, Sept. 25, 2018 /PRNewswire/ --

 Abbott (ABT) today announced one-year results from a real-world, international, multicenter, 941-patient study of the company's Portico™ transcatheter aortic valve replacement (TAVR) system in patients with symptomatic, severe aortic stenosis – a life-threatening narrowing of the heart's aortic valve.

  Sep. 25, 2018 9:57 AM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor 

 AstraZeneca's Imfinzi improved survival in late-stage lung cancer study

 Sep. 24, 2018 1:29 PM ET|By: Douglas W. House, SA News Editor  

 Abiomed (ABMD +8.1%) is up average volume on the heels of its announcement of results from a new analysis of real-world data from its Impella Quality Database that showed a relative increase of 24% in average survival in acute myocardial infarction cardiogenic shock patients since Impella's U.S. approval for cardiogenic shock. 

 Sep. 24, 2018 1:24 PM ET

About: Abbott Laboratories (ABT)  

 The Non-Consensus 

Abbott: MitraClip Success Provides Upside For Stock

  September 24, 2018 07:00 AM EDT 

FARXIGA Achieved a Positive Result in the Phase III DECLARE-TIMI 58 Trial, a Large Cardiovascular Outcomes Trial in 17,000 Patients with Type 2 Diabetes

 Sep. 24, 2018 11:27 AM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor 

 AstraZeneca's Imfinzi OK'd in Europe for advanced lung cancer

 TOKYO and CHERTSEY, England, Sept. 24, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)   

Astellas Receives Positive CHMP Opinion for XTANDI® (enzalutamide) for Adult Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer

 Sep. 18, 2018 8:24 AM ET|About: AstraZeneca Group plc (AZN)|By: Mamta Mayani, SA News Editor   

AstraZeneca's FASENRA shows safety and sustained efficacy in long-term phase III BORA trial in severe eosinophilic asthma

  September 18, 2018 06:59 AM EDT

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY

European Medicines Agency Validates Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Multiple Myeloma

   Sep. 18, 2018 7:22 AM ET|By: Douglas W. House, SA News Editor  

The European Medicines Agency (EMA) accepts for review Bristol-Myers Squibb's (NYSE:BMY) marketing application seeking approval for EMPLICITI (elotuzumab), in combination with Celgene's (NASDAQ:CELG) POMALYST (pomalidomide) and low-dose dexamethasone, for the treatment of adult patients with multiple myeloma (MM) 

 DUBLIN - September 18, 2018 - Medtronic plc (NYSE:MDT)  

(GLOBE NEWSWIRE via COMTEX) --Medtronic Receives FDA Approval for Revised TAVR Labeling and Begins Investigational Study of Low Risk Patients with Bicuspid Valves 

 Sep. 17, 2018 7:25 AM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor 

 AstraZeneca's PT010 shows treatment benefit in late-stage COPD study

 Mon September 24, 2018 9:00 PM|PR Newswire|About: AMGN 

 BLINCYTO® (blinatumomab) Approved In Japan For The Treatment Of Relapsed Or Refractory B-cell Acute Lymphoblastic Leukemia

Sep. 14, 2018 4:50 PM ET  | About: Roche Holding Ltd ADR (RHHBY), RHHBF 

Roche Holding's (RHHBY) Virtual Late Stage Pipeline Event 2018 - Slideshow

 Sat September 15, 2018 2:00 AM|Business Wire|About: PFE

NEW YORK--(BUSINESS WIRE)-- 

Pfizer Inc. (PFE) today announced results from its Phase 2a study of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841, a tyrosine kinase (TYK) 2/JAK1 inhibitor, 

  by john carroll — on September 14, 2018 08:37 AM EDT 

 According to the Albany Times-Union, Regeneron $REGN had already told officials last month that they were expanding their plans for manufacturing, office and lab space in Rensselaer, boosting their initial hiring plans from 1,100 to 1,500 while blueprinting an extra 300,000 square feet of space for the complex. 

  
Zach Hartman  Sep. 14, 2018 8:00 AM ET 

Merck Tightening Its Grips On Front-Line Lung Cancer

  By The ASCO Post
Posted: 9/13/2018 2:20:30 PM
Last Updated: 9/13/2018 5:04:27 PM 

(FDA) today approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) 

  TARRYTOWN, N.Y. and PARIS, Sept. 15, 2018 /PRNewswire/ 

Positive Phase 3 Results Presented for Dupixent® (dupilumab) Show Significant Improvement on Multiple Measures of Disease Severity in Adolescents with Moderate-to-Severe Atopic Dermatitis TARRYTOWN, N.Y. and PARIS, Sept. 15, 2018 /PRNewswire/ 

 Pharmaceutical Business Review

Sep. 13, 2018 5:40 PM ET  

  INDIANAPOLIS, Sept. 13, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE : LLY ) 

• New Lilly Diabetes Center of Excellence Established at the Indiana Bioscience Research Institute
• New center will be a central Indiana nexus for advanced diabetes research and talent attraction

 Sep. 14, 2018 8:22 AM ET 

 Canaccord Genuity LLC -  bullish on medical diagnostic firms 

Pure-plays with M&A potential: ILMN, HSKA, GNMK, QDEL, EXAS, TTOO, HTGM, OraSure Technologies (NASDAQ:OSUR) and Natera (NASDAQ:NTRA). 

  FierceBiotech  by Conor Hale | 

Sep 25, 2018 2:12pm 

 Abbott’s valve-repairing MitraClip improves survival after heart damage

  SEPTEMBER 13, 2018 

AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress

 Keith Speights
(TMFFishBiz)

Sep 13, 2018 at 6:30AM

 This big biotech might look more like a big pharma with sluggish growth but great dividends -- at least temporarily.

 Sep. 13, 2018 2:17 PM ET 

FDA OKs AstraZeneca's Lumoxiti for type of leukemia

  September 12, 2018 

Gilead to Develop Hepatitis B Therapies Using Precision's ARCUS Genome Editing Platform

 Sep. 19, 2018 7:18 AM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor 

Reuters reports that AstraZeneca (NYSE:AZN) is all in in China, leveraging partnerships with tech giants Alibaba and Tencent, smart cancer diagnostics, all-in-one diabetes kits and artificial intelligence systems to improve ambulance pick-ups to become a broad healthcare provider there.

  CARLSBAD, Calif., Sept. 18, 2018 /PRNewswire/ -- Thermo Fisher Scientific, Inc., the world leader in serving science, has licensed CRISPR technologies from the Broad Institute and ERS Genomics (foundational University of California IP) to bolster its genome editing intellectual property (IP) portfolio.  

 April 09, 2018

Top 10 Sequencing Companies

#1. Illumina Revenues: $2.752 billion in 2017

After years of dominating high-end NGS technologies, Illumina in January announced the launch of a markedly smaller system, the one-cubic-foot iSeq 100 sequencer. At $19,900, the iSeq 100 is a bargain compared to the company’s $50,000 MiniSeq or its NovaSeq, which sells for close to $1 million—with Illumina  

  RARITAN, NJ, March 15, 2018 – 

Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer 

 BEERSE, BELGIUM, September 7, 2018 

European Commission expands labelling for Janssen’s INVOKANA® and VOKANAMET® to include positive data on cardiovascular outcomes 

September 13, 2018 11:35 AM|Business Wire 

FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis

  September 13, 2018 9:20 AM|PR Newswire 

AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress

 eptember 13, 2018 at 7:00 AM EDT 

FDA TO REVIEW EYLEA® (AFLIBERCEPT) INJECTION FOR THE TREATMENT OF DIABETIC RETINOPATHY

 NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ -- AbbVie (NYSE : ABBV ) 

AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis

  Sep. 12, 2018 6:55 AM ET 

 FDA grants priority review to Merck’s sBLA for KEYTRUDA as monotherapy for treatment of locally advanced or metastatic NSCLC

 EAST HANOVER, N.J., Sept. 12, 2018 /PRNewswire/ 

Novartis announces NEJM publication of landmark PARADIGMS study demonstrating significant benefit of Gilenya® in children and adolescents with relapsing multiple sclerosis

 WEDNESDAY, SEPTEMBER 12, 2018 2:01 AM EDT 

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY)

Bristol-Myers Squibb’s Novel, Oral, Selective TYK2 Inhibitor Delivered Significant Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis in Phase 2 Trial 

 September 11, 2018 04:05 PM Eastern Daylight Time FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) 

 Gilead and Galapagos Announce Filgotinib Meets Primary and All Key Secondary Endpoints in First Phase 3 Study in Rheumatoid Arthritis

 Tuesday, September 11, 2018 6:45 am EDT 

 Merck’s ZERBAXA® (ceftolozane and tazobactam) Met Primary Endpoints of Non-Inferiority Compared to Meropenem in Pivotal Phase 3 Study of Adult Patients with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

SEPTEMBER 11, 2018 

Minimal Residual Disease Negativity Data, a Measure of Undetectable Disease, Added to VENCLEXTA® (venetoclax tablets) Label

 Tuesday, September 11, 2018 - 8:20amEDT

Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) 

BAVENCIO® (AVELUMAB) PLUS INLYTA® (AXITINIB) SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL IN PREVIOUSLY UNTREATED PATIENTS WITH ADVANCED RENAL CELL CARCINOMA IN PHASE III STUDY